Leominster,
Massachusetts
01453
Purpose:
The study team is developing an e-learning course to train obstetric providers to address
perinatal mood and anxiety disorders. The study team will conduct a formative evaluation of
the e-learning course with 10 obstetric providers and revise/refine the course based on
feedback and then conduct a summative evaluation using a cluster Randomized Controlled Trial
(RCT). The three-arm cluster RCT will evaluate the effectiveness of 1) a virtual
implementation protocol and e-learning/toolkit as compared to 2) e-learning/toolkit alone as
compared to 3) treatment-as-usual. Effectiveness will be evaluated based on rates and quality
of care for perinatal mood and anxiety disorders. Using 2:2:1 randomization, the study team
will randomize a minimum of 15 to a maximum of 25 obstetric practices into three groups: (1)
virtual implementation protocol plus e-learning/toolkit (n=6 to 10); (2) e-learning/toolkit
alone (n=6 to 10); and (3) treatment-as-usual (n=3 to 5), which will yield a maximum of 1000
patient charts evaluated for care received from obstetric providers in the randomized
practices. Charts from 40 patients per practice will be evaluated at 3 different time points.
Study summary:
The objective of this cluster RCT is to evaluate the effectiveness of adding an
implementation protocol to the e-learning/toolkit in comparison to the e-learning/toolkit
alone in comparison to treatment-as-usual among a maximum of 1000 patients receiving care
from 15 - 25 obstetric practices regarding the rates and quality of care for perinatal mood
and anxiety disorders. Using 2:2:1 randomization, we will randomize 15 - 25 obstetric
practices into three groups: (1) virtual implementation protocol plus e-learning/toolkit (n=6
- 10); (2) e-learning/toolkit alone (n=6 - 10); and (3) treatment-as-usual (n=3 - 5).
The study team will conduct a baseline practice and provider assessment which will inform
restricted randomization based on existing approaches to screening for perinatal mood and
anxiety disorders and the clinical care of perinatal women who screen positive. Pre- and
post-intervention data will be obtained through individual provider surveys to evaluate
perinatal mood and anxiety disorder care practices, knowledge, and attitudes. Rates and
quality of care for perinatal mood and anxiety disorders will be assessed pre- and post-
using our established approach and tool to evaluate practice readiness to evaluate and
address perinatal mood and anxiety disorders (Masters et al., submitted). Our tool quantifies
the extent to which assessment, treatment, monitoring, and transfer of care for perinatal
mood and anxiety disorders is documented in patient medical records and provides benchmarks
to measure the extent to which obstetric practices successfully integrate perinatal mental
health care into their workflow over time. Records will be reviewed from the initiation of
prenatal care through postpartum care for given pregnancies, for all abstracted charts.
Participants in all phases of the project will complete the following: (1) a demographic
questionnaire (pre-), (2) a knowledge test (pre- ,post- and final post assessment), (3) a
practices and attitudes survey (pre-, post- and final post assessment), and (4) chart
abstraction (pre- and post-) . The participants in the virtual implementation protocol plus
e-learning/toolkit and e-learning/toolkit alone group will also complete a usability and
satisfaction survey (post-test). All practices will also be asked to facilitate a medical
record review/chart abstraction of a total of 120 patient files, 40 pre-pandemic and 40 post
pandemic first wave and 40 post e-learning/implementation.
Criteria:
Inclusion Criteria:
- licensed independent providers e.g. Ob/Gyn attendings and residents, family medicine,
Maternal Fetal Medicine physicians (attending/fellow), certified nurse midwives, nurse
practitioners, and physician assistants)
Exclusion Criteria:
- providers from the participating practices that are unable to consent,
- individuals who are not yet adults,
- prisoners
- non-English speaking participants in the study.
Pregnant women will not be excluded from participation in the study.
Primary Contact:
Principal Investigator
Nancy Byatt, DO, MS, MBA, FACLP
University of Massachusetts Medical School/UMass Memorial Health
Padma Sankaran, MA
Phone: 508-856-8505
Email: Padma.sankaran@umassmed.edu
Location Contact:
Leominster, Massachusetts 01453
United States
Betty Ann Cirillo, MD
Phone: 978-466-4550
Site Status: Recruiting